Trials / Recruiting
RecruitingNCT05936580
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery - an International, Open-label, Non-controlled Study (NuDIMENSION)
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- Sponsor
- Octapharma · Industry
- Sex
- Female
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery
Detailed description
Female patients with mild to moderate haemophilia A will often need FVIII concentrates to provide haemostatic cover during major surgery. This prospective, open-label, non-controlled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of Nuwiq in women/girls over 12 with haemophilia A undergoing major surgery requiring FVIII treatment
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nuwiq | Nuwiq is a purified B-domain-deleted FVIII glycoprotein synthesised by a genetically engineered human embryonic kidney cell line (HEK 293F). |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2023-07-10
- Last updated
- 2026-01-13
Locations
15 sites across 10 countries: United States, Finland, France, Germany, Italy, Serbia, Spain, Switzerland, United Kingdom, Uruguay
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05936580. Inclusion in this directory is not an endorsement.